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RecruitingNCT07820254Updated Sep 15, 2026

Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

An observational study in Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The goal of this observational study is to learn about the inspiratory flow rate capability in patients with pulmonary fibrosis (IPF or PPF) when using inhaler devices with different resistances. The main questions it aims to answer are:

What is the peak inspiratory flow rate (PIFR) that patients with pulmonary fibrosis can achieve through a medium-resistance inhaler device?

What is the peak inspiratory flow rate (PIFR) that patients with pulmonary fibrosis can achieve through a high-resistance inhaler device?

What is the inspiratory time (EIT) for each resistance level?

Participants will use a portable device called In-Check™ DIAL G16, which simulates the resistance of different dry powder inhalers. Each participant will perform two breathing tests at a medium-resistance setting and two breathing tests at a high-resistance setting, with a 2-minute rest between settings. The device measures how fast air is breathed in and how long each breath lasts.

This study will enroll 60 patients diagnosed with IPF or PPF at Shanghai Pulmonary Hospital. Participants will be involved for approximately 30 to 60 minutes, including training on how to use the device and the breathing tests. The study involves no drugs or invasive procedures.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis
  • Progressive Pulmonary Fibrosis

Keywords

  • Peak Inspiratory Flow Rate
  • Inspiratory Flow Rate
  • Dry Powder Inhaler
  • Inhaler Device
  • Device Resistance
03

In context

Idiopathic Pulmonary Fibrosis

576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.

This study's planned enrollment of 60 is below the median of 152 across 165 observational studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A total of 60 patients with pulmonary fibrosis (IPF or PPF) diagnosed according to the ATS/ERS/JRS/ALAT 2022 guidelines will be enrolled at Shanghai Pulmonary Hospital. Eligible participants are aged 18-80 years, either sex, with FVC ≥ 45% of predicted and DLCO > 25% of predicted within 2 months before screening. All participants will perform inspiratory flow tests at medium and high device resistances.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18-80 years (inclusive), either sex.
  2. Diagnosis of pulmonary fibrosis (IPF or PPF) according to the ATS/ERS/JRS/ALAT 2022 guidelines (with traceable diagnostic evidence such as medical records, confirmed by a radiologist).
  3. Forced vital capacity (FVC) ≥ 45% of predicted normal value within 2 months before screening.
  4. Diffusing capacity for carbon monoxide (DLCO) > 25% of predicted normal value within 2 months before screening.
  5. Voluntary participation with written .

Exclusion criteria

Exclusion Criteria:

  1. Patients with impaired consciousness, dementia, or various psychiatric disorders.
  2. Patients unable to operate the inspiratory flow measurement device as instructed by the investigator.
  3. Patients with major diseases or conditions other than the IPF under study that, in the investigator's judgment, may put the patient at risk by participating in the trial.
  4. Any participant deemed unsuitable for enrollment by the investigator.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pulmonary Fibrosis Patients

    Patients aged 18-80 years with a diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) according to the ATS/ERS/JRS/ALAT 2022 guidelines. Participants will perform inspiratory flow tests using the In-Check™ DIAL G16 device at both medium-resistance and high-resistance settings. No investigational drug or intervention is administered.

06

What researchers measure

Primary outcomes

  1. Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance

    Peak inspiratory flow rate (PIFR, L/min) will be measured using the In-Check™ DIAL G16 device at the medium-resistance setting. Each participant will perform two breathing tests at this setting. The mean PIFR of the two valid measurements will be recorded.

    Time frame: Single visit (approximately 30-60 minutes)

  2. Peak Inspiratory Flow Rate (PIFR) at High Device Resistance

    Peak inspiratory flow rate (PIFR, L/min) will be measured using the In-Check™ DIAL G16 device at the high-resistance setting. Each participant will perform two breathing tests at this setting. The mean PIFR of the two valid measurements will be recorded.

    Time frame: Single visit (approximately 30-60 minutes)

Secondary outcomes

  1. Inspiratory Time (EIT) at Medium and High Device Resistances

    Inspiratory time (EIT, seconds) will be measured using the In-Check™ DIAL G16 device at two resistance settings: medium resistance and high resistance. Each participant will perform two breathing tests at each resistance setting. The mean EIT of the two valid measurements at each resistance level will be recorded and compared between the two settings.

    Time frame: Single visit (approximately 30-60 minutes)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 15, 2026
StartActual
Jan 10, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07820254
Responsible party
Jiuwu Bai (Associate Chief Physician, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
Sep 15, 2026
Start date
Jan 10, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 15, 2026

Study contacts

Jiuwu Bai
Contact
yv59@163.com
+86 13651602925

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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